Benign Solitary SolidPhase 3NCT00150150
Laser Therapy of Benign Thyroid Nodules
A Phase 3 study testing Interstitial laser photocoagulation in people with Benign Solitary Solid and Cystic Thyroid Nodules, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Nodular goitre is common in the general population and less than 5% of the patients who undergo surgery for solitary thyroid nodules have cancer, in absence of clinical suspicion. Nodules left untreated seem to have a slight growth potential in borderline iodine-deficient areas. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Benign Solitary Solid, Cystic Thyroid Nodules
- What is being tested?
- Interstitial laser photocoagulation
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2001to Mar 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a solitary solid thyroid nodule confirmed by ultrasonography
- Patients with a solitary cystadenoma (cystic part more than 2 mL) confirmed by ultrasonography
- Patients with an autonomous functioning thyroid nodule.
Who cannot join
- No family history of thyroid cancer
- Prior radiation towards the neck
- Fine needle biopsy without valid diagnostic criteria for benign thyroid disease
- Nodules larger than 4 cm (largest diameter)
- Suspicion of malignancy
- Increased serum calcitonin
Show all 10Show fewer
- Pregnancy or lactation
- Alcohol, medicine or drug abuse
- No safe contraception
- Physical or psychic condition that hinders corporation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Odense University Hospital
Odense, Funen, 5000
About this study
Official title: Ultrasound Guided Interstitial Laser Photocoagulation on Benign Thyroid Nodules
Nodular goitre is common in the general population and less than 5% of the patients who undergo surgery for solitary thyroid nodules have cancer, in absence of clinical suspicion. Nodules left untreated seem to have a slight growth potential in borderline iodine-deficient areas. Interstitial laser photo-coagulation (ILP) is a procedure for local hyperthermia and photocoagulation, allowing minimally invasive treatment of benign tumors, including thyroid nodules. The aim of these studies are to evaluate if ILP will be useful in reducing the volume of the benign thyroid nodule and thyroid function will be unaffected in euthyroid patients, and normalized in pretoxic- and toxic thyroid nodules. The investigations are listed below:
- Randomized study of interstitial laser photocoagulation for benign solitary cold thyroid nodules - one versus two or three treatments
- Randomized study of interstitial laser photocoagulation for benign solitary autonomous thyroid nodules - 131I versus laser ablation
- Interstitial laser photocoagulation for benign thyroid cystadenomas. - a feasibility study.
- Conditions
- Benign Solitary Solid, Cystic Thyroid Nodules
- Being tested
- Interstitial laser photocoagulation
- Keywords
- Interventional ultrasound, interstitial laser theraphy, tumor ablation, nodule reduction, adverse effects, patient satesfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interstitial laser photocoagulationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy and feasibility repeated ILP treatments in a prospective randomised study where the nodule and thyroid volume are measured 1, 3, 6 and 12 months after the ILP.
In the study of patients with a cystadenoma the measures will be done like wise, but also the recurrence of the cystic part will be measured.
Patients with an autonomous functioning nodule measurements of thyroid function are performed 1,2, 3, 6, 9 and 12 months after the ILP or 131I therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJan 2001
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Solitary SolidStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Helle Døssing, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150150
- Sponsor's protocol ID
- 017
- Status last verified
- Mar 2007
- First submitted
- 6 Sep 2005
- Last updated
- 27 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Interstitial Laser Photocoagulation on Benign Thyroid Nodules
- ClinicalTrials.gov ID
- NCT00150150
- Acronym / sponsor ID
- 017
- Conditions
- Benign Solitary Solid, Cystic Thyroid Nodules
- Keywords
- Interventional ultrasound, interstitial laser theraphy, tumor ablation, nodule reduction, adverse effects, patient satesfaction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2001
- Study completion
- Mar 2006
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nodular goitre is common in the general population and less than 5% of the patients who undergo surgery for solitary thyroid nodules have cancer, in absence of clinical suspicion. Nodules left untreated seem to have a slight growth potential in borderline iodine-deficient areas. Interstitial laser photo-coagulation (ILP) is a procedure for local hyperthermia and photocoagulation, allowing minimally invasive treatment of benign tumors, including thyroid nodules. The aim of these studies are to evaluate if ILP will be useful in reducing the volume of the benign thyroid nodule and thyroid function will be unaffected in euthyroid patients, and normalized in pretoxic- and toxic thyroid nodules. The investigations are listed below:
- Randomized study of interstitial laser photocoagulation for benign solitary cold thyroid nodules - one versus two or three treatments
- Randomized study of interstitial laser photocoagulation for benign solitary autonomous thyroid nodules - 131I versus laser ablation
- Interstitial laser photocoagulation for benign thyroid cystadenomas. - a feasibility study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a solitary solid thyroid nodule confirmed by ultrasonography
- Patients with a solitary cystadenoma (cystic part more than 2 mL) confirmed by ultrasonography
- Patients with an autonomous functioning thyroid nodule.
Key exclusion criteria (10 listed)
- No family history of thyroid cancer
- Prior radiation towards the neck
- Fine needle biopsy without valid diagnostic criteria for benign thyroid disease
- Nodules larger than 4 cm (largest diameter)
- Suspicion of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interstitial laser photocoagulation | Procedure or surgery | – |
Primary outcome
To evaluate the efficacy and feasibility repeated ILP treatments in a prospective randomised study where the nodule and thyroid volume are measured 1, 3, 6 and 12 months after the ILP.
In the study of patients with a cystadenoma the measures will be done like wise, but also the recurrence of the cystic part will be measured.
Patients with an autonomous functioning nodule measurements of thyroid function are performed 1,2, 3, 6, 9 and 12 months after the ILP or 131I therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helle Døssing, MD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interstitial laser photocoagulation in people with Benign Solitary Solid and Cystic Thyroid Nodules, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy and feasibility repeated ILP treatments in a prospective randomised study where the nodule and thyroid volume are measured 1, 3, 6 and 12 months after the ILP.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2007.